https://www.techdirt.com/articles/20200324/18071944167/fda-wont-say-when-gilead-applied-orphan-status-covid-19-treatment-calling-it-secret.shtml

I'm still pretty ticked off about the FDA's absolute bullshit decision to grant remdesivir "orphan drug" status for COVID-19 status. As I explained in the post yesterday, orphan drug status is supposed to be for rare diseases, in order to create an extra incentive for drug makers to find and deploy drugs to treat those diseases with a smaller than usual market. It would be ridiculous to argue that COVID-19 fits the bill. However, as the law in the US currently stands, the definition of a "rare" disease, is one that effects fewer than 200,000 people. The problem -- and the loophole that Gilead Sciences is exploiting here -- is that there's no concept of time and infection rate. The law was written with an idea that the rate of a disease would be relatively constant, so if you apply for orphan drug status at under 200k possible cases, it would remain that way.

Gilead, instead, is exploiting this loophole by basically rushing to the FDA before we'be even tested COVID-19 enough to know how widespread it is, and before we have enough real data or understanding of how wide it has spread. However, given what's happening around the country and the globe, to argue that this is a small market drug that needs extra protections is obviously ludicrous. Even worse, under the law, having the disease later impact more than 200k people is not a reason that the FDA can remove the status.